Application of Cervical Elastography in Obstetrics

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-03-04

Study Completion Date

2021-01-25

Brief Summary

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The purpose of this study is to develop cervical elastography nomograms using Samsung's novel technology "E-cervix" and determine its ability to predict preterm birth.

During each sonogram in which cervical lengths are measured, 5 additional cervical indices will be collected using Samsung's E-cervix technology. Each index will then be separated based on characteristics to create a nomogram for singletons, twins, and those with interventions already in place (i.e. cerclage and/or progesterone) at the time of their E-cervix assessment.

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Detailed Description

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Conditions

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Cervical Elastography

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cervical Elastography

During each sonogram in which cervical lengths are measured, 5 additional cervical indices will be collected using Samsung's E-cervix technology. Each index will then be separated based on characteristics to create a nomogram for singletons, twins, and those with interventions already in place (i.e. cerclage and/or progesterone) at the time of their E-cervix assessment.

Samsung's E-cervix technology

Intervention Type DEVICE

While patients are having their routine cervical ultrasound assessments which requires a 5 minute time period, we will use the built-in software to obtain additional E-cervix measurements to evaluate the consistency of the cervical os. This will be done within the standard 5 minute period which is typically done to observe for dynamic changes. The measurements will be obtained with the same sonogram machine, using updated software.

Interventions

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Samsung's E-cervix technology

While patients are having their routine cervical ultrasound assessments which requires a 5 minute time period, we will use the built-in software to obtain additional E-cervix measurements to evaluate the consistency of the cervical os. This will be done within the standard 5 minute period which is typically done to observe for dynamic changes. The measurements will be obtained with the same sonogram machine, using updated software.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Women who present for early screening or level II ultrasound, aged 18 to 50 years, provides written Informed consent and is willing to comply with protocol requirements, and obtained cervical length and measurements using the E-cervix software/hardware